- Presentation of the case at the interdisciplinary tumor-board attended by
hepatobiliary surgeons, oncologists, hepatologists and radiologists

- Women who are not breastfeeding and are using effective contraception if sexually
active, who are not pregnant and agree not to become pregnant during the 12 months
thereafter. A negative pregnancy test before inclusion into the trial is required for
women < 50 years.

- Men who agree not to father a child during participation in the trial or during the
12 months thereafter.

Outcome Measure:

Outcome Description:

Dose limiting toxicities will be assessed to define the maximum tolerated dose (MTD) of gemcitabine in combination with fixed doses of cisplatin and FUDR. DLTs are per protocol prespecified AE or laboratory abnormalities observed during the first 6 weeks of study treatment. The MTD is one dose level below the dose level that caused DLTs in ≥ one third of patients (2 or more in a cohort of 6 patients), as determined by a traditional 3+3 algorithm.

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Panagiotis Samaras, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Zurich, Department of Oncology

Authority:

Switzerland: Swissmedic

Study ID:

ONK-USZ-003

NCT ID:

NCT01692704

Start Date:

April 2012

Completion Date:

December 2013

Related Keywords:

Cholangiocellular Carcinoma

Carcinoma

Cholangiocarcinoma

Name

Location

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